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Completed

NCT Number: NCT05150964

Measuring Comfort and Clarity With Low Gain Feature in Pediatric Hearing Aid Users

Comfort and clarity of speech will be measured in hearing impaired children age 8-17 using standard speech processing algorithm with a soft speech enhancer feature, referred to as the Adaptive Situational Gain (ASG) feature in study documents.

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Key information

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Arizona State University

Tempe, Arizona, 85281, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of mild, moderate, or moderate-severe sensorineural hearing loss
  • Must use oral mode of communication
  • must speak English

Exclusion criteria

-

Treatment and study plan

Phonak Audeo hearing aid

Device

receiver in the canal devices with custom earmolds

Primary outcomes

  1. Speech Reception Threshold

    Time frame: Initial appointment (day 1 of study) and 2nd appointment (Day 14 of study)

    A familiar spondee word list is presented at varying dB (decibel) levels. Threshold is defined as the lowest dB level at which a correct response occurs for two out of three ascending trials. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session, and counterbalanced across participants. Each session consisted of testing with the ASG (Adaptive Situational Gain) feature on and off. The lower the number (dB level), the softer the participant is able to repeat the words correctly two out of three times.

  2. Word Recognition Score With Words Presented at 40 dB SPL (Decibel Sound Pressure Level) and 70 dB SPL.

    Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

    Familiar monosyllabic word list presented at 40 dB and 70 dB. Percentage of words correctly repeated is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. The higher the score, the better the word recognition in each condition.

  3. Multi-word Recognition at 40 dB SPL and 70 dB SPL

    Time frame: Initial appointment (Day 1 of study) and 2nd appointment (Day 14 of study)

    Out of a list of seven words, the participant repeats back as many words as they can recall. Percentage of correct words repeated back is calculated. Testing was completed in two, two-hour test sessions occurring two weeks apart. One fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. A higher percentage score indicates better multi-word recognition.

  4. Nonword Detection Presented at 40 dB SPL and at 70 dB SPL.

    Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

    A list of 10 3-word phrases are presented to the participant. The participant indicates if the phrase contains a nonsense word by selecting the numbered response button (i.e. "1", "2", or "3") that corresponds to the position oof the nonsense word in the phrase. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different fitting prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off. . The score is the percent correct, a higher score is better.

  5. Rapid Word Learning With Stimuli Presented at 40 dB SPL and at 70 dB SPL.

    Time frame: Initial appointment (Day 1 of study) and 2nd appointment (day 14 of study)

    A word learning task used to determine participant's ability to associate novel/nonsense words with novel images as rapidly as possible. Five nonsense words are paired with five novel images displayed on response buttons. The words are presented randomly 10 times each. The participant selects one picture per word. Scores are presented as percent correct. A higher percentage indicates better word learning. Testing was completed in two, two-hour test sessions occurring two weeks apart. A different prescription, NAL (National Acoustic Laboratory) or DSL (Desired Sensation Level) was selected for each test session and counterbalanced across participants such that one test session consisted of testing with one prescription, either NAL or DSL, but with both levels (40 and 70 dB) and with both ASG (Adaptive Situational Gain) settings, on and off.

  6. Subjective Preference for the Adaptive Situational Gain Feature With Each Fitting Formula

    Time frame: 2nd appointment (day 14 of study)

    Participants will rank preference for the ASG feature (either on or off) in each fitting (NAL and DSL) after listening to audio file.

Sponsors and collaborators

Lead sponsor

Sonova AG

Industry

Collaborators

  • Arizona State University

Registry information

Official study title

Measuring Comfort and Clarity Using Low Gain Feature in Pediatric Hearing Aid Users

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Dec 9, 2021
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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